Excipient Control Strategies in China - Pharmaceutical Technology

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Excipient Control Strategies in China
As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.

Pharmaceutical Technology

In the past, excipients used in China were regulated in the same manner as drugs or active pharmaceutical ingredients (APIs). The domestic implementation of licensing requirements was somewhat inconsistent for excipients, however. SFDA proposes to separate the regulation of excipients to facilitate improved control of quality for both domestic and imported excipients. The goals of their proposed excipient regulations are to improve the quality of excipients, minimize safety risks, and to align SFDA regulations with international standards. In developing the excipient regulations, SFDA has proposed to use the basic principles of its drug regulations as a foundation for excipient regulation. The proposed regulations, however, do not recognize the significant differences between excipients, APIs, and drug products in terms of typical international regulatory requirements.

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas), a trade association of manufacturers of excipients and drug products, has led an industry coalition representing excipient producers and users that works with SFDA to clarify the requirements for obtaining a Chinese import license and to assist SFDA in achieving its goal of improved excipient quality and safety. IPEC-Americas representatives have attended meetings with SFDA to discuss the differences between excipient regulations in the US, Europe, and Japan and the proposed excipient regulations in China. A coalition coordinated by the International Pharmaceutical Excipients Council (IPEC) has requested several changes to the proposed regulations to achieve better harmonization with international standards and requirements. The IPEC Coalition includes IPEC Americas, IPEC Europe, and the Japanese Pharmaceutical Excipients Council (JPEC).

Status of proposed licensing regulation

The IPEC Coalition, in collaboration with the US Department of Commerce, presented the industry's concerns to SFDA at a meeting of the Joint Commission on Commerce and Trade (JCCT) in March 2006. This discussion, along with several follow-up meetings in April 2006, resulted in a fairly favorable first step toward improved excipient regulation. The IPEC Coalition and other participants provided SFDA with information about the regulation of excipients in the US, Europe, and Japan and identified problem areas in SFDA's proposed regulations that would significantly affect both excipient manufacturers seeking import licenses and pharmaceutical companies who would use these materials in China.

SFDA informed the participants that, unlike in most developed countries where pharmaceutical manufacturers essentially regulate their use of excipients with limited regulatory agency oversight, China's government must be responsible for excipient quality. SFDA believes that many Chinese pharmaceutical manufacturers do not have good systems in place to properly qualify excipient suppliers and control excipient quality. SFDA believes that the government must step in to provide adequate protection to Chinese consumers. Accomplishing this goal may require some type of excipient licensing system, according to the agency.

On the other hand, SFDA wants to draft regulations based on appropriate international standards and does not want to impose unrealistic regulations on imported excipients. The agency expects to be able to review the same type of information used to establish excipient quality and safety that is required by international regulatory authorities during the drug-registration process. Since most regulators outside China do not require significant detailed information to be submitted for compendial excipients, SFDA may relax its proposed license requirements for these types of materials.

SFDA and the Coaltion agreed that detailed safety and manufacturing information should be required for the licensing of new excipients and that the regulations should reflect the different needs for evaluating compendial excipients versus new excipients.

SFDA stated that it will study the excipient GMPs and other guidelines provided by the IPEC Coalition to further revise its excipient regulations. SFDA expressed a desire to learn from other countries' success and to use that experience to develop excipient regulations for China. SFDA also noted that although the new excipient regulations have been proposed, no firm implementation date had been set, and that it was unlikely that they will be finalized until 2008. SFDA will use the time to carefully review and assess the documents supplied to them, as well as the various presentations made during its meetings with IPEC Coalition representatives.

One outcome of the 2006 meetings was the recognition of the need to hold an excipient conference in China to discuss how excipients are regulated globally. Such a conference would facilitate SFDA's collaboration with industry for a mutually beneficial resolution of the licensing requirements. In 2007, the IPEC Coalition has continued to help SFDA develop excipient regulations that are science-based and achievable without causing undue regulatory burden that may result in some excipient manufacturers exiting the marketplace.


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